Package leaflet: Information for the user

NEURABEN 100 mg + 150 mg + 500 mcg hard capsules

Benzoiloxymethylthiamine, pyridoxine hydrochloride, cyanocobalamin
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

What Neuraben is and what it is used for
What you need to know before taking Neuraben
How to take Neuraben
Possible side effects
How to store Neuraben
Contents of the pack and other information

1. What Neuraben is and what it is used for

Neuraben contains benfoxythiamine, pyridoxine hydrochloride and cyanocobalamin,
which belong to the category of vitamin-based medicines.
The active substance benfoxythiamine is a rapidly absorbable form of vitamin B1,
pyridoxine hydrochloride is vitamin B6, and cyanocobalamin is vitamin B12.
Neuraben is used for the treatment of polyneuritis due to deficiency of vitamins
B1, B6 and B12.
Polyneuritis is a neurological disease caused by inflammation of several nerves
occurring simultaneously.

2. What you need to know before taking Neuraben

Do not take Neuraben:

if you are allergic to any of the active substances (benzylthiamine, pyridoxine hydrochloride or cyanocobalamin), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Neuraben.
Other medicines and Neuraben
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pyridoxine (vitamin B6), one of the active ingredients in Neuraben, may reduce the therapeutic effects of levodopa.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no data indicating that Neuraben should be avoided during pregnancy or breastfeeding.
Driving and using machines
Currently, there is no evidence suggesting that Neuraben may impair the ability to drive or operate machinery. If you have any doubts, consult your doctor or pharmacist.
Neuraben contains sunset yellow, a colouring agent, which may cause allergic reactions.

3. How to take Neuraben

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule three times a day. Swallow the capsule whole with a little water. The capsules must not be chewed.
Ask your doctor or pharmacist how long you should continue taking Neuraben.

If you take more Neuraben than you should
If you accidentally take too many Neuraben capsules, contact your doctor or pharmacist. Neuraben is generally well tolerated and, to date, there is no evidence that this medicine may cause toxic effects. If you have any doubts, consult your doctor or pharmacist.

If you forget to take Neuraben
If you forget to take a capsule of this medicine, take it as soon as you remember. Neuraben can be taken at any time of the day.

If you stop taking Neuraben
If you wish to stop treatment with Neuraben, consult your doctor or pharmacist. There are no specific recommendations for discontinuing treatment with Neuraben.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone will experience them.
Neuraben is generally well tolerated and no toxic effects are known.
Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, consult your doctor or pharmacist. You may also report side effects
directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store Neuraben

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. Pack contents and other information

What Neuraben contains
The active substances are benzoxythiamine, pyridoxine hydrochloride, cyanocobalamin.
Each hard capsule contains 100 mg of benzoxythiamine, 150 mg of pyridoxine hydrochloride, 500 mcg of cyanocobalamin.
The other components are: talc, magnesium stearate, polyethylene glycol 6000, titanium dioxide (E171), sunset yellow (E110) (see section 2), gelatin.
Description of the appearance of Neuraben and pack contents
Transparent PVC/aluminum blister.
Neuraben is available in a carton containing 30 hard capsules for oral use.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Bioindustria LIM S.p.A.
Via De Ambrosiis 2
15067 Novi Ligure (AL)